Devices and methods for stabilizing tissue and implants

ABSTRACT

An implant for repairing a joint between a first bone and a second bone includes a first section constructed of a substantially rigid material and a graft constructed of soft tissue having a first end and a second end. The first section has a first end surface configured for positioning against the first bone. The graft is configured for stabilizing the first section relative to the first bone. A first fastener is configured for mounting to the graft and the first section to anchor the graft to the first section. A second fastener is configured for mounting to the graft and the first bone to anchor the graft to the first bone.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.11/258,795, filed Oct. 26, 2005, which claims the benefit of U.S.Provisional Patent Application No. 60/622,095, filed Oct. 26, 2004, theentirety of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention generally relates to devices and methods forrepairing and stabilizing tissue and implants. Specifically, the presentinvention provides devices and methods for repairing, reconstructing,augmenting, and stabilizing joints of the body, and more particularly,the knee and joints of the spine (including intervertebral discs andadjacent bones).

BACKGROUND OF THE INVENTION

During a surgical procedure, tissue is either intentionally oraccidentally displaced, torn, or fractured to create a pathway to adesired operation site. In doing so, this tissue is damaged to a pointwhere it may not function properly. After the intended surgicalprocedure or implantation is performed at the operation site, the skinincision is approximated. Currently, however, the other tissue like themuscles, ligaments, tendons, cartilage, bones, etc. which were damagedto create the pathway are not necessarily repaired or reconstructed. Forexample, following spinal surgery, a frequent complication is lateinstability where there is shearing antero-posteriorly or superiorinferiorly due to excess motion because the ligaments have been damagedduring surgical exposure. This complication may lead to degenerativedisc disease and lower back pain.

Various methods and devices have been disclosed for repairing tissue.For example, U.S. Pat. No. 6,425,919 issued to Lambrecht discloses adisc herniation constraining device for implantation into the disc. Theconstraining device includes a fastener, a barrier, and a support memberconnecting the fastener and barrier. The barrier closes a defect in theannulus of the disc, while the fastener supports the position of thebarrier. The barrier is placed between the annulus and the nucleus ofthe disc. The barrier may include a sealant and an enlarger.

In another example, U.S. Pat. No. 6,592,625 issued to Cauthen disclosesa collapsible patch which is inserted through a surgical incision orrupture of the annulus. The patch is positioned within the subannularspace. The patch expands to bridge the incision or rupture therebyoccluding the aperture from the interior of the disc and preventingmigration of nucleus pulposus.

U.S. Pat. No. 6,679,889 issued to West, Jr. et al discloses a method andapparatus of repairing the anterior cruciate ligament. The deviceenables the surgeon to independently apply a desired tensile load ontoindividual strands of a multiple-stranded soft tissue graft. The deviceis equipped with structure for fastening or otherwise attaching thedevice to a patient's limb during the conditioning and pre-tensioningprocedure.

Additionally, U.S. Pat. No. 6,699,286 issued to Sklar discloses methodsand apparatus of making repairs with graft ligaments. The method forgraft ligament reconstruction includes harvesting a graft ligamentconsisting entirely of soft tissue. The graft ligament is compactedthrough compression so as to significantly reduce the cross-sectionalarea and increase the density of the collagen material of the graftligament. The compressed graft ligament is deployed within the humanbody.

Various methods and devices have been disclosed for inserting an implantwithin the body. For example, U.S. Pat. No. 5,108,438 issued to Stonediscloses a mesh skirt to anchor a prosthetic intervertebral disc. Theimplant includes a dry, porous, volume matrix of biocompatible andbioabsorbable fibers which may be interspersed with glycosaminoglycanmolecules. The matrix is adapted to have an outer surface contoursubstantially the same as that of a natural intervertebral disc. A meshmember extends from the lateral surface of the implant. Afterimplantation, the mesh member may be sutured to adjacent tissue toanchor the disc in place. The mesh member may function in this capacityuntil sufficient tissue ingrowth occurs to provide that function.

In another example, U.S. Pat. No. 6,733,531 issued to Trieu discloses aspinal implant which is anchored using a device having an elongatedanchoring body, such as an anchoring rod, and at least one securingmember attached to the anchoring rod. The anchoring body or rod isconfigured to anchor, hold, or otherwise retain a spinal implant. Thesecuring members are spaced apart along the length of the anchoring rodand may define a region for disposing an implant therebetween. Theanchoring rod has a first end and a second end, wherein the first end issecurable to an adjacent vertebra.

Once tissue has been repaired or an implant has been inserted within thebody, the repaired region and surrounding tissue may be stabilized toenhance healing. U.S. Pat. No. 6,652,585 issued to Lange discloses aspine stabilization system including a flexible member attachable to aportion of the spinal column. The member includes components that areoriented and function similar to the natural fiber orientation of theanterior longitudinal ligament and annulus tissue. The use of componentsresist loading applied by extension and rotation of the spine, while theflexibility of the member does not subject it to the compressive loadingof the spinal column segment to which it is attached.

In addition, U.S. Pat. No. 6,293,949 issued to Justis et al. discloses adevice for stabilizing the spinal column. The device includes alongitudinal member sized to span a distance between at least twovertebral bodies and being at least partially formed of a shape-memorymaterial exhibiting pseudoelastic characteristics at about human bodytemperature. The longitudinal member is reformed from an initialconfiguration to a different configuration in response to the impositionof stress caused by relative displacement between the vertebral bodies,and recovers toward the initial configuration when the stress is removedto thereby provide flexible stabilization to the spinal column.

There exists a need for devices and methods for repairing,reconstructing, augmenting, and securing tissue or an implant duringsurgery and “on the way out” after surgery has been performed at anintended operation site. Upon completion of the intended surgery, tissuemay be compressed to other tissue or an implant to improve healing. Hardtissue, for example, may require rigid fixation while soft tissue torequire flexible fixation. The repair, reconstruction, and augmentationof tissue and the securing of implants “on the way out” of the bodyafter performing a surgical procedure creates a stabilized and enhancedhealing environment

SUMMARY OF THE INVENTION

The present invention provides for the repair, reconstruction,augmentation, and securing of tissue or implants during a surgicalprocedure and “on the way out” after the surgical procedure has beenperformed. Hard and soft tissue at and around the operation site andtissue between the operation site and the skin incision may becompressed and/or rebuilt so that tissue-function may be at leastpartially restored and the operation region may be stabilized forenhanced healing. This could be ligament repair, tendon repair, musclerepair, bone repair, cartilage repair, and repair of any other tissuetype. Ligaments may be fastened to ligaments; ligaments to bones; bonesto bones; ligaments to muscles; muscles to muscles; tissue grafts tobone; tissue grafts to ligaments; grafts to grafts; and any othercombination of tissue and implants. It is further contemplated that themethods and devices of the present invention may be utilized withminimally invasive techniques.

In accordance with one aspect of the present invention, a method forstabilizing a body joint is provided. A fastener is positioned incontact with first body tissue on one side of the joint. Anotherfastener is positioned in contact with second body tissue on the otherside of the joint. A suture is placed between the fasteners andtensioned. The tensioned suture is secured to the fasteners to restrictnormal movement of the joint. The fasteners may be positioned in contactwith the outer surface of the body tissues or inside of the bodytissues. The suture may be positioned adjacent to the joint, through thejoint, or in combination.

The body tissues may be bones, muscles, ligaments, tendons, nerves,skin, organs, cartilage, fascia, and blood vessels. The bones andligaments may be bones and ligaments of the knee, ankle, elbow, wrist,feet, hand, hip, shoulder, jaw, and spine. Specifically, bones of theknee may include the femur, tibia, and patella. Ligaments of the kneemay include the medial collateral ligament, lateral collateral ligament,posterior oblique ligament, arcuate ligament, oblique poplitealligament, anterior cruciate ligament, and posterior cruciate ligament.Bones of the spine may include transverse process, pedicle, facet,spinous process, posterior arch, odontoid process, posterior tubercle,lateral articular process, uncinate process, anterior tubercle, carotidtubercle, odontoid process, lamina, and vertebral body. Ligaments of thespine may include the anterior longitudinal ligament, posteriorlongitudinal ligament, interspinous ligaments, supraspinous ligament,ligamentum flavum, intertransverse ligament, facet capsulary ligament,ligamentum nuchae, and ligaments of the sacrum and coccyx spine.

A tubular member may be positioned between the fasteners, and the suturemay be placed within the tubular member such that a portion of thetubular member contacts the first body part and another portion of thetubular member contacts the second body part thereby maintaining thebody parts in alignment with each other.

In accordance with another aspect of the present invention, there isprovided a method for approximating an incision in tissue. A suture ispositioned in portions of tissue located on opposite sides of theincision. The proximal and distal ends of the suture extend from thetissue and are adjacent the incision. A fastener is placed transverse tothe incision with the ends of the suture disposed within at least onechannel of the fastener. The suture is tensioned and secured to thefastener to thereby approximate the incision. The tissue may be bone,muscle, ligament, tendon, skin, organ, cartilage, and blood vessels.

Additionally, two fasteners may be positioned generally parallel to anincision with the first fastener placed on one side of the incision andthe second fastener placed on the opposite side of the incision. Asuture may be positioned in portions of tissue located on opposite sidesof the incision with the middle section of the suture slidably disposedwithin at least one channel of the first fastener and the end portionsof the suture disposed within at least one channel of the secondfastener. The suture may be tensioned and secured to the fasteners tothereby approximate the incision.

In accordance with another aspect of the present invention, a fasteneris provided. The fastener includes an elongated member and at least onechannel extending therethrough generally perpendicular to thelongitudinal axis of the elongated member. A portion of the outersurface of the fastener may be concave, flat, and/or convex.

There is also provided a method of using a fastener. At least a portionof the surface of the fastener is placed in contact with tissue. Thefastener may be placed in contact with an outer surface of the tissueand/or the inner portion of the tissue. A portion of the surface of thefastener may be flat, convex, or concave. A convex portion of thefastener may be placed in contact with a concave portion of the tissue.A flat portion of the fastener may be placed in contact with a flatportion of the tissue. A concave portion of the fastener may be placedin contact with a convex portion of the tissue. In these configurations,the shaped portions of the fasteners mate with the tissue.

In accordance with yet another aspect of the present invention, afastener assembly is provided. The assembly includes a plurality offastener members, each fastener member having at least one channelextending therethrough. A plurality of connecting members links thefastener members to each other. The fastener members may be linkedtogether end to end, side to side, or end to side. When linked together,the fastener members may form a linear, circular, rectangular, J, L, orU configuration. The connecting members may be hinges, pins, ball andsocket, interconnecting loops, hooks, flexible filaments and/or rigidmembers. There may be two or more connecting members which link adjacentfastener members. The channels of the fastener members may be generallytransverse to the longitudinal axis of the fastener member. Eachfastener member may include two or more channels, and the channels maybe generally parallel to each other.

Furthermore, a fastener strip or assembly is provided. The fastenerstrip or assembly includes a plurality of fastener members disposed on aflexible strip. Each fastener member has at least one channel extendingtherethrough. The channel may be generally transverse to thelongitudinal axis of the fastener member. The fastener members arepositioned on the flexible strip to form a linear, circular,rectangular, J, L, and/or U configuration. The fastener members may beaffixed to the upper surface of the flexible strip. The fastener membersmay be affixed to the upper surface of the flexible strip with adhesive.The flexible strip may also have adhesive on its lower or bottom surfacefor adhesion to tissue. Such adhesives may include cyanoacrylateadhesives, hydrogel adhesives, monomer and polymer adhesives, fibrin,polysaccharide, Indermil® or any other biocompatible adhesive. Theflexible strip may be bioabsorbable, bioerodible, degradable,biodegradable, expandable, and/or hydrophilic.

There is also provided a method for using a fastener assembly. Thefastener assembly is positioned against tissue. A suture or sutures arepositioned within the tissue and through the suture assembly to securethe assembly to the tissue. In one embodiment, the assembly is placedover an incision in the tissue. The fastener members are positioned suchthat channel of the fastener members are located on each side of theincision. A suture or sutures are positioned within the portions oftissue on opposite sides of the incision and through the fastenerassembly. The suture or sutures are tensioned and secured with thefastener members. The type and configuration of the fastener assembly isdetermined with respect to the shape or configuration of the tissue. Theshape of the incision also determines the shape of the fastenerassembly.

In accordance with a further aspect of the present invention, a totaldisc replacement implant is provided. The implant includes a superior orupper portion made of a rigid material. The upper surface of thesuperior portion is configured to adjoin to a cut portion of a superioror upper vertebra. The implant also includes an inferior or lowerportion made of a rigid material. The lower surface of the inferiorportion is configured to adjoin to a cut portion of an inferior or lowervertebra. The implant further includes a middle portion made of aflexible material. The middle portion is affixed to the lower surface ofthe superior portion and the upper surface of the inferior portion.

The superior and inferior portions of the implant may include polymeric,composite, metallic, ceramic, and expandable material. The portions mayalso include synthetic bone and body tissue like bone, collagen,cartilage, and ligaments. The portions may also be bioabsorbable,bioerodible, degradable, and biodegradable. The middle portion of theimplant may include rubber, gel, foam, polymer, collagen, and bodytissue. The total disc replacement implant may be made of a plurality ofcomponents; that is, the implant may be modular. The components may beconnected with each other to form the implant. The components maymechanically interlock with one another. Each component may have a sizeapproximately the same as the length of the incision through which thecomponents are inserted.

In addition, there is provided a method for total disc replacement. Anincision is made through tissue for access to the spine. The dimensionsof the incision may be minimized to reduce trauma to surrounding tissuelike muscle, ligaments, tendons, and cartilage. The vertebra locatedsuperior to the damaged disc being replaced is cut. The cut may be madeon the lower or bottom portion of the superior vertebra. The cut may beplanar or multiplanar. The superior vertebra may be cut withoutdisturbing or at least minimally disturbing the adjacent ligaments,cartilage, and muscles. The cut may be angled to avoid damaging orloosening the spinal ligaments like the anterior and posteriorlongitudinal ligaments.

The vertebra located inferior to the disc being removed is cut in asimilar manner, except the upper surface of the inferior vertebra iscut. Once cut, the cut portions of vertebrae and the intervertebral discare removed through the incision. The cut vertebrae are further preparedfor receiving an implant. The total disc replacement implant or modularimplant is positioned between the cut superior and inferior vertebrae. Amodular implant may be positioned one component at a time or alreadyassembled. The implant is anchored to the surrounding tissue like theadjacent vertebral bodies. Any ligaments, muscles, cartilage, tendons,or other body tissue cut or damaged during the procedure is repairedprior to closing the incision. Finally, the incision is approximated.

In accordance with another aspect of the present invention, a tissuealignment sleeve is provided. The sleeve includes a tubular memberhaving a wall. The interior surface of the wall is generally smooth. Theexterior surface of the wall includes means for gripping and creatingfriction. The gripping means may include threads, a plurality of raisedregions, and a plurality of circumferential elevated areas or rings. Thewall may include a plurality of openings for tissue ingrowth andoutgrowth. The wall may include one or more longitudinal slits such thatthe tubular member or sleeve may be bendable to increase and decreasethe diameter of the sleeve.

There is further provided a method of using a tissue alignment sleeve. Achannel is created in tissue. The sleeve is positioned within thetissue. The gripping or friction means of the sleeve holds the sleevewithin the tissue. The tissue may include first and second portions.When positioned within the first and second portions of the tissue, theportions are aligned and maintained in position relative to each other.The first and second portions may be portions of bone on opposite sidesof a fracture. The portions may be tissue of a body joint. The portionsmay be bones of a joint located on opposite sides of the joint, suchthat when the sleeve is positioned, movement of the joint is restricted.

A sleeve with at least one longitudinal slit may be positioned with thechannel created in tissue. The diameter of the sleeve may be decreasedby closing the gap in the longitudinal slit. In a decreased diameter,the sleeve may be inserted into the channel. Once positioned, thediameter of the sleeve may be increased thereby engaging the grippingmeans with the tissue. A suture or sutures may be placed through thelumen of the sleeve to secure tissue located at the ends of the sleeve.After the sleeve has gripped the adjacent tissue with the grippingmeans, therapeutic substances or graft material (autogenic, allogenic,xenogenic, or synthetic) may be packed into the tubular member.

In accordance with a further aspect of the present invention, a methodfor stabilizing an implant is provided. A first fastener is positionedin contact with tissue located adjacent the implant. A second fasteneris positioned in contact with tissue located adjacent the implantgenerally opposite the first fastener. A suture is placed between thefasteners and in contact with the implant. The suture is tensioned, andthe fasteners are secured to the tensioned suture such that the suturetransmits force to the implant. The suture may be positioned in contactwith the surface of the implant. The suture may also be positionedwithin the implant.

In addition, a method for stabilizing an implant within a body isprovided. A first fastener is positioned in contact with the implant. Asecond fastener is positioned in contact with tissue located adjacentthe implant. A suture is placed between the fasteners. The suture istensioned, and the fasteners are secured to the tensioned suture toanchor the implant to the tissue. The first fastener may be positionedwithin the implant or on the surface of the implant. The suture may beplaced against or within the implant.

In accordance with another aspect of the present invention, there isprovided a method for anchoring an implant for directional expansionwithin the body. A first fastener is positioned in contact with thefirst side of an expandable implant. A second fastener is positioned incontact with tissue located adjacent a second side of the implant whichis opposite the first side. A first suture is positioned between thefasteners and tensioned. The first suture is secured with the first andsecond fasteners. In this configuration, the first side of theexpandable implant is restricted from expanding, but all other sides ofthe implant can expand.

For further restriction of expansion, a third fastener is positioned incontact with the second side of the implant. A fourth fastener ispositioned in contact with tissue located adjacent the first side of theimplant. A second suture is positioned between the third and fourthfasteners. The second suture is tensioned and secured with thefasteners. The second side of the implant is restricted from expanding.To further restrict expansion of the implant, more fasteners and suturesmay be positioned as previously described such that the implant islimited to expansion in one, two, or more directions.

The sutures may be positioned in contact with the expandable implantsuch that the sutures transmit force to the implant thereby anchoringthe implant and further restricting expansion.

In accordance with a further aspect of the present invention, a devicefor anchoring an implant is provided. The device includes a pouchdimensioned and configured for receiving an implant. The pouch has anaccess port for inserting the implant. At least one anchoring point isconnected with the pouch. The device may further include a flap attachedto the pouch for closing the access port. The implant may be expandable,and when positioned in the pouch, the implant generally expandsprimarily in the direction of the access port. The pouch may include aplurality of access ports. An expandable implant placed in a pouch witha plurality of access ports expands primarily in the directions of theaccess ports.

In accordance with another aspect of the present invention, there isprovided a method for repairing a ligament. A fastener is positioned incontact with the ligament adjacent the first side of a damaged region ofthe ligament. Another fastener is positioned in contact with theligament adjacent a second side of the damaged region which is generallyopposite the first side. A suture is positioned between the fasteners.The suture is tensioned and secured with the fasteners such that theligament is tightened. The suture may be positioned through theligament. The suture may also be positioned through tissue adjacent thedamaged area. The tissue may be spine tissue such as one or morevertebrae and one or more intervertebral discs. The ligament may be aligament of the spine such as the anterior or posterior longitudinalligament, or any of the previously identified ligaments. The damagedregion may be a loosened ligament area, a torn ligament area, or amissing ligament area.

Furthermore, a method for reconstructing a ligament is provided. Atissue graft is positioned adjacent a damaged region of the ligament. Afirst fastener is positioned in contact with the tissue graft on a firstside of the damaged region. A second fastener is positioned in contactwith the tissue graft on a second side of the damaged region which isgenerally opposite the first side. A suture is positioned between thefasteners with the suture passing through the tissue graft and ligament.The suture is tensioned and secured with the fasteners to hold thetissue graft against the ligament. The tissue graft may includeligamentous tissue or bone tissue. The ligament may be a ligament of thespine. The suture may be positioned within tissue located adjacent theligament. The tissue may be spine tissue including one or more vertebraeand one or more intervertebral discs.

Moreover, there is provided another method for reconstructing aligament. A tissue graft is positioned adjacent a damaged region of theligament. A first fastener is positioned in contact with the tissuegraft on a first side of the damaged region. A second fastener ispositioned in contact with tissue adjacent the ligament. A suture ispositioned between the fasteners with the suture passing through thetissue graft and ligament. The suture is tensioned and secured to thefasteners such that at least a portion of the tissue graft is held tothe ligament. The tissue graft may include ligamentous tissue or bonetissue. The ligament may be a ligament of the spine like the anterior orposterior longitudinal ligament. The suture may be positioned within thetissue adjacent the ligament. The tissue may be spine tissue includingone or more vertebrae and one or more intervertebral discs.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

A more complete understanding of the present invention, and theattendant advantages and features thereof, will be more readilyunderstood by reference to the following detailed description whenconsidered in conjunction with the accompanying drawings wherein:

FIGS. 1A-1H illustrate multiple embodiments of fasteners and fastenerassemblies;

FIGS. 2A-2G shows a plurality of embodiments of tissue alignmentsleeves;

FIG. 3 illustrates the repair of the annulus of an intervertebral discas well as stabilization of the spinal joint;

FIG. 4 illustrates a total intervertebral disc replacement implant;

FIG. 5 illustrates an embodiment for the anchoring of an implant;

FIG. 6 shows a further embodiment for the anchoring of an implant;

FIG. 7 illustrates anchorage of an expandable implant for directionalexpansion;

FIGS. 8A-8C show multiple embodiments of implant pouches;

FIG. 9 illustrates ligament repair and stabilization;

FIG. 10 shows ligament reconstruction and stabilization;

FIGS. 11A-11C illustrate ligament augmentation/reinforcement;

FIG. 12 shows a laminectomy site;

FIG. 13 illustrates stabilization of the cervical spine and head; and

FIG. 14 shows decompression and stabilization of the spinal column.

DETAILED DESCRIPTION OF THE INVENTION

The devices and methods of the present invention provide for the repair,reconstruction, augmentation, and securing of tissue and/or implantsduring a surgical procedure and “on the way out” after the surgicalprocedure has been performed but before the skin incision has beenclosed. Tissue at and around the operation site and tissue between theoperation site and skin incision is rebuilt so that tissue-function maybe at least partially restored and the operation region may bestabilized for enhanced healing.

The devices used to repair, reconstruct, augment, and/or secure tissueor implants may be any biocompatible fastener described herein or foundin the prior art. Examples of fasteners, implants, and their methods ofemployment may be found in U.S. Pat. Nos. 5,163,960; 5,403,348;5,441,538; 5,464,426; 5,549,630; 5,593,425; 5,713,921; 5,718,717;5,782,862; 5,814,072; 5,814,073; 5,845,645; 5,921,986; 5,948,002;6,010,525; 6,045,551; 6,086,593; 6,099,531; 6,159,234; 6,368,343;6,447,516; 6,475,230; 6,592,609; 6,635,073; and 6,719,765. Otherfastener types are disclosed in U.S. patent application Ser. Nos.10/102,413; 10/228,855; 10/779,978; 10/780,444; and Ser. No. 10/797,685.The above cited patents and patent applications are hereby incorporatedby reference.

The fasteners may be, but are not limited to, degradable, biodegradable,bioerodible, bioabsorbable, mechanically expandable, hydrophilic,bendable, deformable, malleable, riveting, threaded, toggling, barded,bubbled, laminated, coated, blocking, pneumatic, one-piece,multi-component, solid, hollow, polygon-shaped, pointed,self-introducing, and combinations thereof. Also, the fasteners mayinclude, but are not limited to, metallic material, polymeric material,ceramic material, composite material, body tissue, synthetic tissue,hydrophilic material, expandable material, compressible material, heatbondable material, and combinations thereof

The fasteners of the present invention may be linear fixation fasteners.Such fasteners secure tissue or an implant with access to only one sideof the tissue or implant. Generally, the fastener is advanced throughthe tissue or implant, usually through a pre-made passage or without apassage when the fastener is self-introducing. Once placed through thetissue or implant, a distal portion of the fastener expands, biasesoutward, or changes configuration such that the distal portion preventsthe fastener from being pulled back out of the tissue or implant. Theproximal portion of the fastener is secured thereby anchoring the tissueor implant. Examples of linear fixation fasteners are further disclosedin the incorporated references.

The methods and devices of the present invention may be used inconjunction with any surgical procedure of the body. The repair,reconstruction, augmentation, and securing of tissue or an implant maybe performed in connection with surgery of a joint, bone, muscle,ligament, tendon, cartilage, capsule, organ, skin, nerve, vessel, orother body part. For example, tissue may be repaired, reconstructed,augmented, and secured during and “on the way out” followingintervertebral disc surgery, knee surgery, hip surgery, organ transplantsurgery, bariatric surgery, spinal surgery, anterior cruciate ligament(ACL) surgery, tendon-ligament surgery, rotator cuff surgery, capsulerepair surgery, fractured bone surgery, pelvic fracture surgery,avulsion fragment surgery, hernia repair surgery, and surgery of anintrasubstance ligament tear, annulus fibrosis, fascia lata, flexortendons, etc.

Also, tissue may be repaired after an implant has been inserted withinthe body. Such implant insertion procedures include, but are not limitedto, partial or total knee replacement surgery, hip replacement surgery,bone fixation surgery, etc. The implant may be an organ, partial organgrafts, tissue graft material (autogenic, allogenic, xenogenic, orsynthetic), collagen, a malleable implant like a sponge, mesh,bag/sac/pouch, collagen, or gelatin, or a rigid implant made of metal,polymer, composite, or ceramic. Other implants include breast implants,biodegradable plates, porcine or bovine patches, metallic fasteners,compliant bearing for medial compartment of the knee, nucleus pulposusprosthetic, stent, tissue graft, tissue scaffold, biodegradable collagenscaffold, and polymeric or other biocompatible scaffold. The scaffoldmay include fetal cells, stem cells, embryonal cells, enzymes, andproteins.

The present invention further provides flexible and rigid fixation oftissue. Both rigid and flexible fixation of tissue and/or an implantprovides compression to enhance the healing process of the tissue. Afractured bone, for example, requires the bone to be realigned andrigidly stabilized over a period time for proper healing. Also, bonesmay be flexibly secured to provide flexible stabilization between two ormore bones. Soft tissue, like muscles, ligaments, tendons, skin, etc.,may be flexibly or rigidly fastened for proper healing. Flexiblefixation and compression of tissue may function as a temporary strut toallow motion as the tissue heals. Furthermore, joints which include hardand soft tissue may require both rigid and flexible fixation to enhancehealing and stabilize the range of motion of the joint. Flexiblefixation and compression of tissue near a joint may provide motion inone or more desired planes. The fasteners described herein andincorporated by reference provide for both rigid and flexible fixation.

Exemplary Fasteners

The following Examples 1 through 8 which illustrate uses of the presentinvention are for illustrative purposes and are not limiting examples.As mentioned above, any fastener disclosed herein or incorporated byreference may be used with the exemplary methods. To simplify thedisclosure of the present invention, a limited number of fastener typeswill be used to illustrate the exemplary methods. For example, thefasteners disclosed in U.S. Pat. No. 5,921,986 will be used to representany disclosed or known fastener.

As described in the above-mentioned patent, the fasteners may be placedagainst tissue, and a suture may be looped through the tissue with theends of the suture positioned within the fasteners. The suture istensioned, and the ends of the suture are secured using a knot or anyother suitable means for maintaining the tension of the suture betweenthe fasteners. The tensioning of the suture, or similar cable, pin,thread, etc., may be controlled and monitored with sensor technology,like a magnetic sensor, which may unload the pressure if necessary.Other known tensioning apparatus may also be utilized. For example, thetensioning system may be spring loaded, pneumatic, electrical,pisoelectric, and magnetic. The tensioning system may be connected withan introducer or cannula or may be part of a fastener or implant. Thetensioning system may include a read-out display outside the body. Theread-out display may receive tension data through radiofrequency energy,infrared energy, or other suitable energy source.

Additionally, two or more fasteners may be utilized to secure bodytissue and/or an implant. When two fasteners are used, one fastener isplaced against or within one tissue area and the second fastener isplaced against or within another tissue area. The suture is loopedthrough one fastener while the ends of the suture are positioned withinthe second fastener. The suture is tensioned and the ends fastened witha knot or fastened using a device or method disclosed herein orincorporated by reference. In this configuration, the suture includestwo generally parallel legs or portions located between the fasteners.Furthermore, when two fasteners are used, a single suture may beemployed leaving only one leg between the fasteners. In thisconfiguration, each end of the suture is positioned in differentfasteners. The suture may be tensioned and the ends secured. It isfurther contemplated that the fasteners and sutures may be insertedthrough a passage in the tissue or implant. For example, a passage maybe drilled through tissue or implant for insertion of the fastener orsuture. With the fastener in place, these passages may be packed orfilled with tricalcium phosphate (TCP), calcium phosphate, a thermalpolymer, polymethyl methacrylate (PMMA) with hydroxyapatite (HA),polylactic acid (PLA) with HA, and other suitable materials. Thesematerials may harden within the passage and would provide additionalstabilization of the tissue or implant.

FIGS. 1A-1F illustrate exemplary fasteners 30 with at least one channel32. In an exemplary embodiment, FIG. 1A shows a generally cylindricalshaped fastener 30 a. Two channels or slots 32 a for receiving a sutureor other similar filament extend through the fastener 30 a and aregenerally perpendicular to the longitudinal axis 34 of the fastener 30a. FIG. 1B shows a generally half cylindrical shaped fastener 30 b. Thefastener 30 b includes a generally flat surface 36 on one side and anarched surface 38 on the other side. The flat surface 36 may be placedagainst the tissue or implant to provide increased contact area. FIG. 1Cshows a cylindrical shaped fastener 30 c with a hemispheric or concavesurface 40 on one side. This surface 40 may be placed against an implantor tissue, like a bone, which has a convex surface, so that the concavesurface 40 of the fastener 30 c and the convex surface of thetissue/implant are in contact. FIG. 1D shows a generally rectangularfastener 30 d. The fastener 30 d may have a thickness which minimizesprotrusion of the fastener 30 d from the outer surface of the tissue orimplant which it is positioned against.

Although the exemplary fasteners have been described as generallylongitudinal members, it is also contemplated that the fasteners cantake the form of a square, oval, sphere, button, or any other suitableconfiguration.

FIG. 1E shows a fastener assembly 30 e having a plurality of fastenermembers 42 positioned generally parallel to each other with connectingmembers 44 between them. The fastener members 42 may take the form ofany shape described previously or incorporated by reference. Theconnecting members 44 attach the fastener members 42 to each other. Theconnecting members 44 may be hingedly or pivotally connected with thefastener members 42 to allow the fastener assembly 30 e to flex or bend.Alternatively, the connecting members 44 may be made of a flexiblematerial such as a suture, wire, cable, or thread, which could flex orbend. In an exemplary embodiment, the channels 32 e of the fastenermembers 42 are positioned such that a row of channels 46 are alignedover one portion of tissue located on one side of an incision whileanother row of channels 48 are aligned over the other portion of thetissue located on the opposite side of the incision. Multiple suturesmay be used with the fastener assembly for securing tissue or animplant.

Alternatively, the fastener members 30 e may be connected with oneanother with a flexible strip 50. As seen in FIG. 1F, four fastenermembers 42 are affixed to the flexible strip 50 and are generallyparallel to each other and spaced apart from each other. The strip 50may be handled and placed against tissue or an implant therebypositioning all the fastener members 42 at about the same time. In thisregard, the flexible strip 50 can be made of or include graft materialsuch as collagen, demineralized bone, etc. The flexible strip 50 may beexpandable, hydrophilic, bioabsorbable, bioerodible, degradable,biodegradable, or combinations thereof. It may include a therapeuticsubstance such as antibiotics, hydroxypatite, anti-inflammatory agents,steroids, antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein, demineralized bone matrix, collagen, growthfactors, autogenetic bone marrow, progenitor cells, calcium sulfate,immo suppressants, fibrin, osteoinductive materials, apatitecompositions, fetal cells, stem cells, enzymes, proteins, hormones,germicides, and combinations thereof.

The flexible strip 50 may also include an adhesive on one side to adherethe fastener members 42 to the strip 50 and may further include adhesiveof the other side to adhere the strip 50 to tissue or implant. Suchadhesives may include cyanoacrylate adhesives, hydrogel adhesives,monomer and polymer adhesives, fibrin, polysaccharide, Indermil® or anyother biocompatible adhesive.

FIG. 1G shows another fastener assembly 30 g of the present invention.This fastener assembly 30 g is generally L-shaped or J-shaped. Like thefastener assemblies of FIGS. 1E and 1F, the fastener members 42 of FIG.1G may be attached to one another with connecting members 44 or with aflexible strip 50. FIG. 1H shows a U-shaped fastener assembly 30 h forclosing a U-shaped incision in tissue, like those frequently made in theannulus. The rows of channels 46 and 48 of the fastener members 42 arearranged as previously described, with one line of channels 46 on oneside of the incision and the other line of channels 48 of the other sideof the incision.

The type and shape of the incision determine the size and configurationof the fastener assembly used. For example, a U-shaped incision could beclosed with a U-shaped fastener assembly 30 h, and an L-shaped incisioncould be closed with an L-shaped fastener assembly 30 g. The suture orsutures used with the fastener assemblies may be tensioned and securedwith a knot, or alternatively may be secured with devices and methodsdescribed herein and those incorporated by reference.

The exemplary fasteners may be utilized with one or more sutures,filaments, cables, or other similar implant. Generally, one suture maybe used for the fasteners of FIGS. 1A-1D when only one fastener isemployed. When two or more fasteners of FIGS. 1A-1D are used, multiplesutures may be employed. Similarly, the fasteners of FIGS. 1E-1H may usemultiple sutures. The ends of sutures may be placed through the channelsof the fastener members, and the sutures tensioned. Alternatively, asingle suture could be used. That is, the single suture may be threadedin and out of the channels of the fastener members to secure tissue oran implant.

The exemplary fasteners and fastener assemblies of the present inventionmay be formed of any natural or artificial material. For example, theymay be formed from material which is polymeric, metallic, composite,ceramic, or combinations thereof. Furthermore, the fasteners andassemblies may be made of body tissue including bone, collagen,cartilage, ligaments, or tissue graft material like xenograft,allograft, and autograft. They may be bioabsorbable, bioerodible,degradable, biodegradable, mechanically expandable, hydrophilic, andcombinations thereof. The fasteners and assemblies may be made from aporous matrix or mesh of biocompatible and bioresorbable fibers actingas a scaffold to regenerate tissue.

The fasteners and assemblies may also be made of or have a coating madeof an expandable material. The material could be compressed then allowedto expand once sutured to tissue or an implant. Alternatively, thefastener and assembly material could be hydrophilic and expand when itcomes in contact with liquid. Examples of such expandable materials aredesiccated body tissue, foam, and expandable polymers.

Furthermore, the fasteners, fastener assemblies, and implants describedherein and incorporated by reference may include therapeutic substancesto promote healing. These substances could include antibiotics,hydroxypatite, anti-inflammatory agents, steroids, antibiotics,analgesic agents, chemotherapeutic agents, bone morphogenetic protein(BMP), demineralized bone matrix, collagen, growth factors, autogeneticbone marrow, progenitor cells, calcium sulfate, immo suppressants,fibrin, osteoinductive materials, apatite compositions, germicides,fetal cells, stem cells, enzymes, proteins, hormones, cell therapysubstances, gene therapy substances, and combinations thereof. Thesetherapeutic substances may be combined with the materials used to makethe fasteners to produce a composite fastener or implant. Alternatively,the therapeutic substances may be impregnated or coated on the fasteneror implant. Time-released therapeutic substances and drugs may also beincorporated into or coated on the surface of the fastener or implant.The therapeutic substances may also be placed in a bioabsorbable,degradable, or biodegradable polymer layer or layers.

The sutures of the present invention may be made of metallic material,non-metallic material, composite material, ceramic material, polymericmaterial, copolymeric material, or combinations thereof. The sutures maybe degradable, biodegradable, bioabsorbable, or non-biodegradable.Examples of suture materials are polyethylene, polyester, cat gut, silk,nylon, polypropylene, linen, cotton, and copolymers of glycolic andlactic acid. In an exemplary embodiment, the sutures are flexible orbendable. They may be threadlike, monofilament, multifilament, braided,or interlaced. The sutures may have a coating of therapeutic substancesor drugs. For example, the sutures may include antibiotics,hydroxypatite, anti-inflammatory agents, steroids, antibiotics,analgesic agents, chemotherapeutic agents, bone morphogenetic protein,demineralized bone matrix, collagen, growth factors, autogenetic bonemarrow, progenitor cells, calcium sulfate, immo suppressants, fibrin,osteoinductive materials, apatite compositions, fetal cells, stem cells,enzymes, proteins, hormones, and germicides.

FIGS. 2A-2C illustrate exemplary embodiments of another fastener 52. Thefastener or tubular member or sleeve 52 a in FIG. 2A is generallytubular shaped having a wall 54 with an inner surface 56 and an outersurface 58. The inner surface 56 defines a lumen 60 which is dimensionedand configured for receiving a suture, cable, K-wire, or similar device.In another embodiment, FIG. 2B shows a sleeve 52 b with a slit 62through the tubular wall 54. The slit 62 allows the sleeve 52 b to bedecreased in diameter for implantation and increased in diameter afterimplantation for proper alignment of the implantation site. In a furtherembodiment, the sleeve 52 c of FIG. 2C includes two slits 62 in thetubular wall 54 thereby forming two semi-tubular members. Thesemi-tubular members may be placed separately at the implantation sitethen aligned to form a complete tubular member. In another embodiment,the tubular member is a solid member.

The tubular member may be flexible to enable the tubular member to beinserted into a nonlinear passage through the bone. The tubular membermay be formed of metallic material, composite material, ceramicmaterial, polymeric material, or combinations thereof. The tubularmember may be made from a degradable, biodegradable, bioerodible, orbioabsorbable material, such as a polymer, composite, or ceramic. Thetubular member may also include a therapeutic substance to form acomposite tubular member, or the therapeutic substance may be coatedonto the tubular member. Furthermore, therapeutic substances or graftmaterial (autogenic, allogenic, xenogenic, or synthetic) may be packedinto the tubular member.

Additionally, the outer surface 58 of the tubular member 52 may includea friction or gripping means. FIG. 2D shows a portion of the outersurface 58 of the tubular member with threads 64. In FIG. 2E, the outersurface 58 includes raised pebbles, or bumps 66. FIG. 2F illustratesraised ridges or hills 68 around the outer surface 58. In addition to afriction means on the outer surface of the tubular member, the wall ofthe sleeve may include openings 70 for tissue ingrowth, as shown in FIG.2G. It is contemplated that any of the fasteners, fastener assemblies,and implants disclosed herein and incorporated by reference may alsoinclude a friction or gripping means as described above.

It is further contemplated that tissue and implants may be secured withbiologic adhesive, or fasteners disclosed herein and incorporated byreference may be used with the biologic adhesive. Such adhesives mayinclude cyanoacrylate adhesives, hydrogel adhesives, monomer and polymeradhesives, fibrin, polysaccharide, Indermil® or any other biocompatibleadhesive. For example, tissue scaffolds and tissue welding fastenersdisclosed herein or incorporated by reference may be used with adhesiveand an energy source, like ultrasound, RF, laser, electromagnet,ultraviolet, infrared, electro-shockwave, or other suitable energysource, to activate or deactivate the adhesive.

Example 1—Intervertebral Disc Repair

As previously described, the present invention provides devices andmethods for fastening body tissue and/or an implant. One example is thefastening or repair of ligamentous tissue. Ligamentous tissue is found,among other locations, within intervertebral discs of the spinal column.The spinal column is formed from a number of vertebrae which areseparated from each other by intervertebral discs. The intervertebraldiscs stabilize and distribute force between the many vertebrae. As usedherein, “spinal joint” or joint of the spine includes thisintervertebral space.

Generally, intervertebral discs are made of a soft, central nucleuspulposus surrounded by a tough, woven annulus fibrosus. Herniation of adisc is a result of a weakening in the annulus. Symptomatic herniationsoccur when weakness in the annulus allows the nucleus pulposus to bulgeor leak posteriorly toward the spinal cord and major nerve roots. Onetreatment of a herniated, displaced, or ruptured intervertebral disc isa discectomy. This procedure involves removal of disc materialsimpinging on the nerve roots or spinal cord posterior to the disc.Depending on the surgeon's preference, a varying amount of nucleuspulposus is removed from within the disc space either through theherniation site or through an incision in the annulus. In addition to adiscectomy, other surgical procedures where the present invention may beused include a vertebroplasty and kyphoplasty.

FIG. 3 illustrates an exemplary embodiment of repairing anintervertebral disc 80. The disc 80 is located between a superiorvertebra 82 and an inferior vertebra 84. During a discectomy, anincision 86 is made through the annulus fibrosus 88 for the removal ofall or a portion of the nucleus pulposus 90. After the appropriateamount of the nucleus 90 has been removed, the incision 86 isapproximated. In one embodiment showing the closing of the incision 86,a fastener 30 is positioned generally transverse to the incision 86. Thefastener 30 is positioned on the outer surface of the annulus 88 withone channel 32 on one side on the incision 86 and the other channel 32on the other side of the incision 86. A suture 100 is positioned throughthe portions of annulus 88 located on opposite sides of the incision 86in a generally U-shaped, looped, or curved configuration. The ends ofthe suture 100 are placed within the channels 32 of the fastener 30 andtensioned to draw together the two portions of the annulus 88 onopposite sides of the incision 86. The suture 100 is secured to thefastener 30 with a knot or other means disclosed herein or incorporatedby reference. Depending on the length of the incision, a plurality offasteners and sutures may be used to fully close the incision.

One or more additional incisions 86 in the annulus 88 may be necessaryfor increased access to the nucleus 90. These other incisions will alsoneed to be approximated. As seen in FIG. 1, one fastener 30 is placed onone side of the incision 86 generally parallel to the incision 86. Asecond fastener 30 is positioned on the other side of the incision 86.Closure of the incision 86 is accomplished by placing a suture orsutures 100 through the annulus 88 so that the annulus portions onopposite sides of the incision 86 are drawn together when the suture 100is tensioned. The ends of the suture are secured by the fasteners 30.Depending on the length of the incision, more than two fasteners may beutilized to approximate the incision. The closure of the incisionenhances the natural healing and reconstruction of the annulus wall.

While the incisions of FIG. 3 are generally linear, other incisionconfigurations may be made for increased accessibility through theannulus. For example, the incision may be circular, L-shaped, U-shaped,C-shaped, J-shaped, etc. Different configurations and types of fastenersillustrated in FIG. 1 may be used to close these non-linear incisions.Furthermore, these incisions may be made anywhere along the annulus(posterior, anterior, or sides) or between the annulus and vertebralbody.

It is further contemplated that access to the nucleus pulposus may beobtained through a vertebral body. A channel(s) or passage(s) 92 mayextend from the outer side surface of the vertebral body to the adjacentnucleus. The channel may be formed with a bone drill bit and/or a tissueharvesting device as described in U.S. Pat. No. 5,269,785 entitledApparatus and Method for Tissue Removal, which is hereby incorporated byreference. The nucleus pulposus material may be fully or partiallyremoved through the channel 92. Means for removing the material mayinclude suction, scrapper, scooper, syringe, or other similar device.When no new material is required to be implanted in the region where thenucleus pulposus material was removed, the physician may close thechannel 92 with graft material such as autograft material, allograftmaterial, and/or other implantable materials disclosed herein.Alternatively, a plug/seal 93 made of metal, polymer, composite, orceramic may be inserted into the channel 92 at either end of the channelor at both ends of the channel. The plug 93 may be removable for gainingaccess to the nucleus pulposus during a subsequent surgery. In thismethod, the annulus fibrosus is not incised, punctured, or weakenedthereby reducing the healing time of the disc.

Depending on the severity of herniation or damage to the disc, nucleuspulposus replacement material or a nucleus pulposus prosthesis may bepositioned between a superior vertebra and inferior vertebra. One ormore incisions may be made through the annulus for access to thenucleus. The nucleus pulposus may be removed, and the replacementmaterial or prosthesis may be inserted. Alternatively, the nucleuspulposus also remain in place with the replacement material orprosthesis positioned next to or along with the existing nucleuspulposus. Furthermore, the nucleus pulposus can be removed, conditionedor treated, and then re-implanted either alone or with a replacementmaterial. In this regard, the temporarily removed nucleus pulposus canserve as a scaffold seeded with cells or treated with a growth factor orany other of the therapeutic agents disclosed herein. The fasteners andsutures of the present invention may be used to approximate the annulusincisions. Any number of fasteners may be used to fully close theincision.

The nucleus pulposus replacement material or prosthesis may also bepositioned between the superior and inferior vertebrae through avertebral body. As mentioned previously, a passage or channel may bemade through the vertebral body extending from the outer surface to theadjacent nucleus pulposus. All, some, or none of the existing nucleuspulposus may be removed prior to insertion of the replacement materialor prosthesis. In an exemplary embodiment, the replacement material isinjected through the incision or channel in the vertebra and into thenucleus pulposus area. This material may be flowable for injection thenonce injected may become less flowable to form a gel-like material or,alternatively, may become generally solid to form a rubber-likematerial. Additionally, the nucleus pulposus replacement material may beflowable or injected into a balloon or bladder which may be positionedbetween adjacent vertebral bodies.

In another embodiment, the replacement material or prosthesis may berubber-like or gel-like pellets having a configuration which allows themto be passed through the incision or channel. The replacement materialor prosthesis may be expandable so that, once inserted, it can fill theimplant area. The materials or prosthesis may include an adhesive and/ortherapeutic substances, like antibiotics, hydroxypatite,anti-inflammatory agents, steroids, antibiotics, analgesic agents,chemotherapeutic agents, bone morphogenetic protein, demineralized bonematrix, collagen, growth factors, autogenetic bone marrow, progenitorcells, calcium sulfate, immo suppressants, fibrin, osteoinductivematerials, apatite compositions, fetal cells, stem cells, enzymes,proteins, hormones, and germicides.

Surgery of the intervertebral disc may leave the spine with increasedmotion or shear which can cause further disc failure, facet hypertrophy,or arthritis of the facet joints. To stabilize the repairedintervertebral disc “on the way out,” the devices and methods of thepresent invention may be utilized. Flexible fixation of tissue at andnear the operation site may allow compression of tissue and limitedmotion of the repaired intervertebral disc allowing ligaments, theannulus fibrosis, interspinous ligaments, and other soft tissue toproperly heal. Stabilizing one vertebral body to another vertebral bodyunder compression would still allow for some range of motion of thejoint yet prevent disc degeneration.

The vertebral bodies may be stabilized anteriorly and/or posteriorly orwith a hybrid approach such as an anterior-lateral or posterior-lateralapproach. For example, on the anterior side of the spine, two fasteners30 are positioned to secure the ends of a suture 100 placed through theintervertebral disc 80 and through adjacent vertebrae 82 and 84 in acurved or looped configuration. Two other fasteners 30 are positionedagainst or within the vertebrae 82 and 84 to hold the ends of a sutureor sutures 100 placed through the disc 80 and through the adjacentvertebrae 82 and 84 in a generally straight configuration. Two morefasteners 30 are positioned against or within two vertebrae 102 and 104located a distance from the repaired disc 80. A suture or sutures 100are placed between these vertebrae 102 and 104 and tensioned. Thesefasteners and sutures provide stability and an enhanced healingenvironment for the intervertebral disc.

Finally, FIG. 3 illustrates another exemplary embodiment for stabilizingtissue around a repaired tissue region. One fastener 30 is positionedagainst or within an upper spinous process 106 adjacent the repaireddisc 80, while another fastener 30 is positioned against or within alower spinous process 108 also adjacent the repaired disc 80. A sutureor sutures 100 are placed between the fasteners 30 and tensioned. Thisconfiguration and placement of fasteners and sutures limits or preventsthe movement of the repaired disc.

Example 2—Intervertebral Disc Replacement

A damaged intervertebral disc may require replacement instead of justminor repair. The disc may be replaced with a prosthetic disc which mayinclude a biocompatible material such as metal, polymer, composite,ceramic, or combinations thereof. FIG. 4 illustrates a totalintervertebral disc replacement using the devices and methods of thepresent invention. While a disc replacement is shown and describedbelow, it is contemplated that any skeletal region, like a joint, may befitted with an implant, and the implant fastened and stabilized with thesutures, fasteners, and methods disclosed herein and incorporated byreference. For example, a knee replacement component may be affixed tothe femur, tibia, or patella in accordance with the following describedmethods.

A disc replacement component may be positioned between the lower surfaceof a superior vertebra and the upper surface of an inferior vertebra. Inthis configuration, the disc replacement component takes the place ofthe original intervertebral disc and provides the proper spacing betweenthe vertebrae. Such a disc component may be anchored to the surfaces ofthe superior and inferior vertebrae with the fasteners and suturesdescribed herein and incorporated by reference.

Alternatively, and as shown in FIG. 4, the disc replacement implant 110may be larger in height than the normal height of an intervertebraldisc. The implant 110 may include upper 112, middle 114, and lower 116sections. The upper and lower sections 112 and 116 are made of abiocompatible material which allows integration of the bone tissue ofthe vertebral bodies. This material may be polymeric, composite,metallic, ceramic or combinations thereof. Furthermore, the material maybe body tissue including bone, collagen, cartilage, ligaments, or tissuegraft material. The material may be bioabsorbable, bioerodible,degradable, and/or biodegradable.

The upper and lower sections 112 and 116 of the disc replacementcomponent 110 may include therapeutic substances, like antibiotics,hydroxypatite, anti-inflammatory agents, steroids, antibiotics,analgesic agents, chemotherapeutic agents, bone morphogenetic protein,demineralized bone matrix, collagen, growth factors, autogenetic bonemarrow, progenitor cells, calcium sulfate, immo suppressants, fibrin,osteoinductive materials, apatite compositions, fetal cells, stem cells,enzymes, proteins, hormones, and germicides. Finally, the upper andlower sections 112 and 116 may include an expandable material. Thismaterial could be compressed then allowed to expand once implanted.Alternatively, the material could be hydrophilic and expand when itcomes in contact with liquid. Examples of such expandable materials aredesiccated body tissue, foam, and expandable polymers.

The middle section 114 of the disc implant 110 includes a flexible orresilient material. The middle section 114 functions as the originalintervertebral disc. Materials which may be used in the middle section114 include rubber, gel, foam, polymer, collagen, body tissue, or othersuitable material. The middle section 114 may also include an expandablematerial. Furthermore, therapeutic substances such as antibiotics,hydroxypatite, anti-inflammatory agents, steroids, antibiotics,analgesic agents, chemotherapeutic agents, bone morphogenetic protein,demineralized bone matrix, collagen, growth factors, autogenetic bonemarrow, progenitor cells, calcium sulfate, immo suppressants, fibrin,osteoinductive materials, apatite compositions, fetal cells, stem cells,enzymes, proteins, hormones, and germicides may be included in themiddle section 114 of the disc replacement implant 110.

The disc implant 110 is positioned as follows. The superior vertebra 118may be cut to receive the upper section 112 of the disc implant 110,while the inferior vertebra 120 may be cut to receive the lower section116 of the implant 110. The cuts may be made from any side of thevertebral body. However, it is preferred that cutting the vertebrae 118and 120 results in minimal disruption of the surrounding tendons,muscles, nerves, and ligaments, like the anterior and posteriorlongitudinal ligaments. The cuts may be planar and generallyperpendicular to the longitudinal axis of the spine. The cuts may alsobe multi-planar such that the pedicles and facet joints are not affectedor weakened.

The upper, middle, and lower sections 112, 114, and 116 of the implant110 combine to form a height which when the implant 110 is positionedbetween the cut portions of the superior and inferior vertebrae 118 and120, is generally the same height of the normal intervertebral disc andadjacent vertebral bodies. This technique is analogous to a total kneereplacement procedure. The femur, tibia, and patella are cut andprepared for implant components. Once affixed, the knee replacementcomponents return the knee joint to its normal height, configuration,and function. The spinal implant 110 of the present invention issimilar; it returns the spinal column to its normal height and function.

To secure the disc implant 110 to the cut superior and inferiorvertebrae 82 and 84, the sutures, fasteners, and methods of the presentinvention may be used. As seen in FIG. 4, a fastener 30 is positionedwithin or against the superior vertebra 82, while a second fastener 30is placed within or against the upper section 112 of the disc implant110. A suture 100 positioned between the fasteners 30 is tensionedthereby anchoring the implant 110 to the superior vertebra 82. Inaddition, a graft 120, like a tissue graft, is positioned over the lowersection 116 of the implant 110 and the inferior vertebra 84. Twofasteners 30 with sutures hold the graft 120 in place thereby anchoringthe implant 110 to the inferior vertebra 84. To help stabilize theregion around the disc implant 110, a first fastener 30 is positionedwithin or against a spinous process 106, while a second fastener 30 isplaced within or against a different spinous process 108. A suture 100extends between the fasteners 30 and is tensioned to limit movement ofthe spinous processes 106 and 108 and their relative vertebral bodies.

The disc implant 110 is further anchored to the superior and inferiorvertebrae 82 and 84 with fasteners, sutures, and tubular members. Twofasteners 30 are positioned within or against the vertebrae 82 and 84.Two other fasteners 30 are placed within or against the disc implant.Sutures 100 are positioned within tubular members or sleeves 52 thatextend between the fasteners. The tubular members 52 may have a thincylindrical wall which engages the bone of the vertebrae 82 and 84 andmaterial of the implant 110. By inserting the tubular members 52 in suchan orientation, the superior and inferior vertebrae 82 and 84 and discimplant 110 are maintained in alignment.

It is also contemplated that the tubular member or sleeve may be placedwithin ligaments, tendons, muscles, bones, or combinations thereof. Forexample, the tubular member may be positioned in bones, includingtransverse process, pedicles, facets, spinous process, posterior arch,odontoid process, posterior tubercle, lateral articular process,uncinate process, anterior tubercle, carotid tubercle, and vertebralbody. The tubular member may also be positioned in ligaments, includingthe anterior longitudinal ligament, posterior longitudinal ligament,interspinous ligaments, supraspinous ligament, ligamentum flavum,intertransverse ligament, facet capsulary ligament, ligamentum nuchae,and ligaments of the sacrum and coccyx spine.

Following intervertebral disc replacement, the spine and surroundingtissue may be become weakened. To stabilize these regions “on the wayout,” the devices and methods of the present invention may be utilized.Flexible fixation of tissue at and near the operation site may allowcompression of tissue and limited motion of the prostheticintervertebral disc allowing ligaments, the annulus fibrosis,interspinous ligaments, and other hard or soft tissue to properly heal.Stabilizing one vertebral body to another vertebral body undercompression would allow for some range of motion of the joint andprevent disc degeneration and reduce the incidence of postoperativepain.

Example 3—Implant Anchoring

The devices and methods of the present invention may be further used tostabilize an implant positioned within the body. In addition to the typeof implants previously mentioned, the implant may be an organ, partialorgan grafts, tissue graft material (autogenic, allogenic, xenogenic, orsynthetic), a malleable implant like a sponge, mesh, bag/sac/pouch,collagen, or gelatin, or a rigid implant made of metal, polymer,composite, or ceramic. Other implants include breast implants,biodegradable plates, metallic fasteners, rods, plates, screws, spacers,cages, compliant bearing implants for one or more compartments of theknee, nucleus pulposus implant, stents, meniscal implants, tissuegrafts, tissue scaffolds, biodegradable collagen scaffolds, andpolymeric or other biocompatible scaffolds.

Also, fasteners and sutures may be utilized to position bone replacementimplants including joint replacement components such as for the knee andhip, drug delivery implants, pain pumps, spinal implants, dentalimplants, tissue implants, tissue patches such as porcine, bovine, orpatches disclosed in U.S. Pat. No. 6,592,625 to Cauthen, and otherimplants. The previously mentioned patent is hereby incorporated byreference. The implants, fasteners, and sutures may also include cellsbonded to their surface. The cells may be bonded with a biocompatibleadhesive, such as those describe herein, and/or may be bondedelectromagnetically or with vanderwalls forces. While implant anchoringis described below in reference to intervertebral disc implants, itshould be understood that the methods described herein may be used foranchoring any implant with the body.

In FIG. 5, a prosthetic disc implant 130 is positioned between twovertebrae (only one shown) 84. The annulus fibrosis 88 encircles theimplant 130. A fastener 30 is placed within the posterior portion of theannulus 88. A suture 100 loops around and/or through the implant 130,and the suture 100 is secured with the fastener 30. Tensioning thesuture 100 in this configuration stabilizes the implant 130 bypreventing movement of the implant 130 in a posterior-anteriordirection. Two other fasteners 30 are positioned against the annulus 88generally on the sides of the annulus. A suture 100 connects these twofasteners 30 and holds the implant 130 preventing movement in aside-to-side or lateral direction. It is contemplated that the suturesand fasteners used to anchor an implant may extend through or around theimplant.

FIG. 6 illustrates a disc implant 130 stabilized between a superiorvertebra 82 and inferior vertebra 84. A fastener 30 is positioned withinthe implant 130 while another fastener 30 is placed within or againstthe superior vertebra 82. A suture 100 is tensioned between thefasteners 30 to hold the implant 130 to the lower surface of thesuperior vertebra 82. For added stability, a fastener 30 is placedwithin or against the inferior vertebra 84 while another fastener 30 ispositioned against the implant 130. A suture 100 passes through theimplant 130 and the fasteners 30, and the ends of the suture 100 aresecured. Any of the methods and devices described herein or incorporatedby reference may be used to fasten the ends of the suture.

As previously mentioned, the implant may be any object surgically placedwithin the body. The implant may be made from various biocompatiblematerials. Also, the implant may be expandable within the body. Ahydrophilic implant may swell or expand by absorbing liquid. A resilientimplant may be compressed prior to implantation, then expand oncepositioned within the body. It is contemplated that an expandableimplant may be stabilized using any method and device disclosed herein.In addition, the expandable implant may be held with fasteners andsutures such that expansion of the implant may be directed in apreferred direction or directions. Moreover, electromagnetic pulsedenergy may be used to thermally lock a suture to the implant within thebody.

In FIG. 7, an implant 130 is stabilized to a vertebra 84 with multiplesutures and fasteners in a way to allow the implant to expandanteriorly. A first fastener 30 is positioned against the left side ofthe annulus 88, while a second fastener 30 is placed within or againstthe right side of the implant 130. A suture 100 extends between thefirst and second fasteners 30. When tensioned, the suture 100 preventsthe implant 130 from expanding to the right while holding the top of theimplant 130 as well. A third fastener 30 is positioned against the rightside of the annulus 88. A suture 100 is looped around and/or through theimplant 130 and secured with the third fastener 30 to thereby preventthe implant 130 from expanding to the left. A fifth fastener 30 ispositioned against the anterior side of the annulus 88, while a sixthfastener 30 is place within or against the posterior side of the implant130. A suture 100 positioned between the fifth and sixth fasteners 30keeps the implant 130 from expanding in the posterior direction. Giventhis configuration of sutures and fasteners, the implant 130 is limitedto expansion in only the anterior direction. It is contemplated thatother configurations of sutures and fasteners may be used to limit theexpansion of the implant to one or more directions. That is, the implantmay be allowed to expand to the left, right, posterior, anterior, up,down, diagonally, or any combination thereof

The present invention also provides an enclosure 140 for stabilizing andanchoring an implant and furthermore to direct expansion of the implantin zero, one, or more desired directions. FIG. 8A illustrates anenclosure (or pouch, bag, sac, etc) 140 a for an implant. The implantmay be expandable or non-expandable. The pouch 140 may include one ormore anchoring points 142. The anchoring points 142 may be placed on anyof the corners, edges, or other surfaces so that when anchored the pouch140 is properly secured at the desired location and orientation. A flapor lid 144 allows access into the pouch 140 for positioning of theimplant. The flap 144 may be closed and sealed so the entire implant isenclosed. A pouch that completely encloses an expandable implant wouldallow the implant to expand omni-directionally until restricted by thepouch. The lip or flap may be resealable such that the material may beadded to or removed from the pouch inside the body.

The pouch may be made from any natural or artificial material. Forexample, it may be formed from material which is polymeric, composite,metallic, ceramic, or combinations thereof. Furthermore, the pouch maybe made of or include body tissue including bone, collagen, cartilage,muscle, tendon, ligaments, or other tissue graft material. The materialof the pouch may be solid, porous, bioabsorbable, bioerodible,degradable, and/or biodegradable. The pouch may be made from a porousmatrix or mesh of biocompatible and/or bioabsorbable fibers or filamentsacting as a scaffold to regenerate tissue. The fibers or filaments maybe interlaced, braided, or knitted to form the pouch.

The pouch may include or may be filled with therapeutic substances ordrugs, like antibiotics, hydroxypatite, anti-inflammatory agents,steroids, antibiotics, analgesic agents, chemotherapeutic agents, bonemorphogenetic protein, demineralized bone matrix, collagen, growthfactors, autogenetic bone marrow, progenitor cells, calcium sulfate,immo suppressants, fibrin, osteoinductive materials, apatitecompositions, fetal cells, stem cells, enzymes, proteins, hormones, andgermicides. The pouch may further include or be filled with a gelatinwhich may contain a therapeutic agent. The gelatin inside the pouch mayslowly osmotically leak out into the surrounding tissue.

The pouch may also include an adhesive to bond the pouch to the implant,to bond the pouch to the implantation site, and/or bond the flap to thepouch. Such adhesives may include cyanoacrylate adhesives, hydrogeladhesives, monomer and polymer adhesives, fibrin, polysaccharide,Indermil® or any other biocompatible adhesive. A pouch filled with oneor more therapeutic agents may form a drug cocktail implant. Thetherapeutic agents selected to be inserted within the pouch may bespecifically tailored to the needs of the patient. The pouch may befilled outside or within the patient. Once placed within the body, thetherapeutic agent may slowly dissolve and exit the pouch through anosmotic member to reach the surrounding tissue.

In another exemplary embodiment, FIG. 8B shows a pouch 140 b with abi-directional expansion ports 146 on the left and right sides. When anexpandable implant is placed in the pouch 140 and secured at theimplantation site, the implant is restricted in expansion in alldirections except to the left and right. It is contemplated that thepouch 140 may be designed with one or more expansion ports 146 facing inany direction. In FIG. 8C, the pouch 140 c includes a unidirectionalexpansion port 148. The pouch 140 allows the expandable implant toexpand upward. A pouch with an upward or downward pointing expansionport may be particularly useful for prosthetic disc replacement. Onceplaced in the pouch and positioned between two vertebrae, an expandableimplant may expand to increase the space between the vertebrae.

Example 4—Ligament Repair

Instability of joints between bones has long been the cause ofdisability and functional limitation in patients. Joints of themusculoskeletal system have varying degrees of intrinsic stability basedon joint geometry and ligament and soft tissue investment. Ligaments aresoft tissue condensations in or around the joint that reinforce and holdthe joint together while also controlling and restricting variousmovements of the joints. When a joint becomes unstable, either throughdisease or traumatic injury, its soft tissue or bony structures allowfor excessive motion of the joint surfaces relative to each other and indirections not normally permitted by the ligaments.

Common problems associated with excessive joint motion are malalignmentproblems, subluxation of the joint, and possibly joint dislocation.Typically, the more motion a joint normally demonstrates, the moreinherently loose is the soft tissue surrounding the joint. A looseligament or group of ligaments ultimately causes skeletal disorders.However, over tensioning ligaments restricts motion of the joint and canalso cause musculoskeletal problems.

The present invention also provides methods of tensioning a ligament (ortendon) or group of ligaments (or tendons) during a surgical procedureand “on the way out” after the surgical procedure to prevent jointinstability and reduce pain. These methods can be applied to anyligament in the body, including the ligaments of the knee (like theanterior cruciate ligament and iliotibial band), shoulder, elbow, wrist,hip, ankle, hands, and feet. For illustrative purposes, the methods ofthe present invention are described with reference to the spine.

When an intervertebral disc becomes herniated and loses nucleus pulposustissue, the distance between the adjacent vertebrae is reduced from thecompression of the annulus and remaining nucleus pulposus. As a result,the spine ligaments may become relaxed. These ligaments may include, butare not limited to, the anterior longitudinal ligament, posteriorlongitudinal ligament, interspinous ligaments, supraspinous ligament,ligamentum flavum, intertransverse ligament, facet capsulary ligament,ligamentum nuchae, and ligaments of the sacrum and coccyx spine.

FIG. 9 shows an anterior longitudinal ligament 150 which has becomeweakened. The fasteners and sutures of the present invention may be usedto tighten the anterior longitudinal ligament 150 and decreaseanteroposterior translation of the adjacent intervertebral discs. Itshould be understood that the methods described with respect to theanterior longitudinal ligament may also be applied to tightening otherligaments of the body.

A fastener 30 is positioned against the ligament 150 adjacent the upperend of a loosened region 152 of the ligament 150. Another fastener 30 ispositioned against the ligament 150 adjacent the lower end of theloosened region 152. A suture 100 is positioned through the ligament 150and through the fasteners 30. The suture 100 is tensioned therebytightening the loosened region 152 of the ligament 150.

In another embodiment, a fastener 30 is positioned against the ligament150 above a stretched region 154. Another fastener 30 is placed againstthe ligament 150 below the stretched region 154. A suture 100 is placedthrough the ligament 150, adjacent vertebrae 156 and 158, andintervertebral disc 80 in a curved or looped configuration. The suture100 is tensioned to tighten the stretched region 154.

In a further embodiment represented in FIG. 9, one fastener 30 ispositioned against the ligament 150 above a missing or torn ligamentregion 160. Another fastener 30 is positioned against the ligament 150below the missing region 160. The suture 100 is positioned through thesuperior and inferior ends of the ligament 150 at the missing or tornregion 160. The suture 100 is tensioned between the fasteners 30 causingthe ends of the ligament 150 to be drawn together.

To stabilize the spine while a loosened or torn ligament heals, astabilization implant, such as a rod or plate 162, may be positionedadjacent spinous processes 164. The fasteners and sutures of the presentinvention may be used to secure the rod or plate 162 to the spine. Aplurality of fasteners 30 is positioned against the rod or plate 162proximate to each spinous process 164. A second plurality of fasteners30 is placed within or against the spinous processes 164. Sutures 100extend between the fasteners 30 and are tensioned. Once anchored, therod or plate 162 limits movement of the spinous processes 164 relativeto each other thereby limiting movement of the anterior longitudinalligament 150.

It is contemplated that the fasteners of the present invention be placedwithin or adjacent any bone of the body. When used in the knee, forexample, the fasteners may be placed adjacent the femur, tibia, orpatella. Within the spine, an fastener may be positioned adjacent aposterior arch, a spinous process, a lateral or medial articularprocess, a pedicle, odontoid process, uncinate process, a posteriortubercle, carotid tubercle, or a vertebral body.

Example 5—Ligament Reconstruction

The present invention may also be used in ligament or tendonreconstruction. Ligaments are frequently damaged, detached, torn, orruptured as the result of injury or surgery. A damaged ligament canimpede proper motion of a joint and cause pain. Therefore, during or “onthe way out” from a surgical procedure, a ligament may be reconstructedusing a fastener, a tissue graft, and/or a tissue scaffold with orwithout cells.

The devices and methods of the present invention may be used with atissue or artificial graft to tension and stabilize the damagedligament. Any ligament of the body may be repaired using the presentinvention, including the ligaments of the spine, shoulder, elbow, hip,knee, ankle, feet, and hands. The present invention is described inreference to ligaments of the spine including the anterior and posteriorlongitudinal ligaments, interspinous ligaments, supraspinous ligaments,superior costotransverse ligaments, ligamentum flavum, facet capsularyligament, intertransverse ligament, ligamentum nuchae, and ligaments ofthe sacrum and coccyx spine.

In an exemplary embodiment, FIG. 10 shows a damaged anteriorlongitudinal ligament 150. A ligament graft 170 is positioned adjacentthe damaged region 172. A first fastener 30 is placed against theinferior end of the ligament graft 170, while a second fastener 30 ispositioned within or against a vertebral body 174. A suture 100 extendsthrough the graft 170, ligament 150, and vertebra 174. The suture 100 istensioned, and the ends of the suture 100 are secured. Similarly, twofasteners and a suture are positioned at the superior end of theligament graft. To further anchor the ligament graft 170 to the anteriorlongitudinal ligament 150, one fastener 30 is positioned against thegraft 170 on one side of the damaged region 172, and another fastener 30is placed against the graft 170 on the other side of the damaged region172. A suture 100 is placed through the graft 170, ligament 150,adjacent vertebrae 82 and 84, and intervertebral disc 80 in a generallycurved, looped, or C configuration. The suture 100 is tensioned, and theends of the suture 100 secured. It is also contemplated that the curvedor looped suture may be placed through multiple intervertebral discs andvertebrae.

In another embodiment, FIG. 10 shows a graft 170 positioned between twoadjacent vertebrae 82 and 84. The ligament or bone graft 170 ispositioned adjacent the damaged region 172 of the anterior longitudinalligament 150. The graft 170 may be attached using any of the devices andmethods described herein and incorporated by reference. In an exemplaryembodiment, two fasteners 30 are placed at the superior and inferiorends of the graft 170. Two other fasteners (not shown) are positionedwithin or against each vertebra 82 and 84. Sutures are positionedbetween the fasteners and tensioned.

To stabilize the longitudinal ligament 150 while the damaged region 172heals, sutures and fasteners may be placed on the posterior side of thespine for stabilization. One fastener 30 is placed within or against aspinous process 164, while another fastener 30 is positioned within oragainst a pedicle or bone of the facet joint 176. A suture 100 extendsbetween the fasteners 30 thereby limiting movement of the spine. FIG. 10shows an additional stabilization device between an upper and lowerspinous process. In this configuration, the suture and fasteners provideadditional restriction to the movement of the spine.

The ligament or bone graft may be obtained from a variety of sourcesand/or made from various materials. In an exemplary embodiment, theligament graft is made of collagen. The graft could also includeautograft, allograft, or xenograft material. The graft may be a tendongraft, bone-tendon-bone graft, or a meniscus graft. Other material whichmay be used in the formation of the graft is polymer, carbon fiber,PEEK, PTFE, a biodegradable material, elastic or flexible material,Gore-Tex®, or woven fiber. The ligament graft may include therapeuticsubstances. These include antibiotics, hydroxypatite, anti-inflammatoryagents, steroids, antibiotics, analgesic agents, chemotherapeuticagents, bone morphogenetic protein, demineralized bone matrix, collagen,growth factors, autogenetic bone marrow, progenitor cells, calciumsulfate, immo suppressants, fibrin, osteoinductive materials, apatitecompositions, fetal cells, stem cells, enzymes, proteins, hormones, andgermicides.

Use of grafts or patches to repair, reconstruct, and augment tissue,like a ligament, may include patches such as TissueMend® patches,Restore® patches, or similar products.

Example 6—Ligament Augmentation

In addition to ligament repair and reconstruction, the devices andmethods of the present invention may be used for ligament or tendonaugmentation. Ligament augmentation reinforces or supplements naturalligaments. A ligament may be augmented or reinforced after it has beenrepaired or reconstructed. Also, a non-repaired ligament may beaugmented prophylactically. In this case, the augmentation may be usedto increase the load-bearing capacity of the ligament or tendon.Additionally, or alternatively, the augmentation may be used to preventa potential injury to a ligament or tendon. For example, an athlete mayundergo minimally invasive surgery to reinforce a ligament or tendon soas to prevent the ligament or tendon from being injured later in theathlete's career. Many talented athletes' careers are cut short becauseof any injury to a body joint, like the knee, shoulder, ankle, spine,wrist, or hip. If an athlete desired to prevent or at least reduce thechance of sustaining a career ending injury, he/she could have surgeryto augment or “fail-safe” a joint and its ligaments and tendons even ifthere are no other risk factors other than the occupation. Of course,other risk factors, such as genetic predisposition, could be considered,if desired.

The devices and techniques described herein relate to augmenting anyligament or tendon of the body including ligaments of the knee,shoulder, spine, hand, foot, hip, and elbow. For illustrative purposesonly, ligament augmentation is described with reference to the anteriorcruciate ligament (ACL) of the knee. It should be understood that thedescription of augmentation to the knee is not limiting to otherligaments and tendons.

In an exemplary embodiment, fasteners and a suture (or similar devicelike a cable, band, flexible moment arm, pin, rod, or K-wire) may beused to augment a ligament. Referring to FIGS. 11A, 11B, and 11C, afastener 30 may be positioned near one end of the ligament 180, whileanother fastener 30 may be placed near the opposite end of the ligament180. The suture or cable 100 may be placed between the fasteners 30 andmay be generally parallel with the ligament 180. The suture 100 may betensioned, and the ends of the suture 100 secured with the fasteners 30.It is contemplated that multiple fasteners and multiple sutures may beutilized to augment the ligament. For example, a suture 100 may beplaced at an angle to the ligament 180 with the ends of the suture 100secured with fasteners 30. Having multiple sutures at different anglesrelative to each other and/or the ligament may providemultiple-direction augmentation.

In a further exemplary embodiment, a tissue graft or scaffold(reinforcement means) 182 may be used to augment the ligament or tendon180. The graft or scaffold 182 may be configured and include materialsas previously described herein. The graft or scaffold 182 may bepositioned generally parallel to the ligament 180 requiringaugmentation. The ends of the graft 182 may be anchored to bone,ligament, or other tissue using the devices and methods of the presentinvention. For example, one fastener may be positioned in or against thegraft while another fastener may be placed in or against adjacenttissue. A suture may be tensioned between the fasteners, and the ends ofthe suture secured with the fasteners. Also, a fastener 30 may bepositioned against the graft or adjacent tissue, and a suture 100 may bewrapped around the adjacent tissue and graft one or multiple times toform a band or latching. The suture 100 may be tensioned and securedwith the fastener 30. It is contemplated that multiple grafts and/orscaffolds may be used to augment the ligament or tendon. For example,grafts or scaffolds may be at different angles to the ligament toprovide augmentation in multiple directions.

Furthermore, it is contemplated that the graft or scaffold 182 used toaugment the ligament or tendon may be secured to tissue using aband-like device 184. The band 184 may be wrapped around the graft orscaffold 182 and adjacent tissue, like a bone 186. The band 184 may be abiocompatible elastic band, a tissue graft, a polymeric or metallic tie(like a wire tie), or other suitable banding apparatus.

The suture and/or graft (reinforcement means) 182 used to augment theligament or tendon may be placed parallel or diagonal to the ligament ortendon. Also, the suture and/or graft may be helically or spirallywrapped around the ligament or tendon. The ligament or tendon may behelically or spirally wrapped around the suture or graft. Thereinforcement means may be positioned within or interwoven, braided, orweaved into the ligament or tendon.

As previously described, an athlete may desire to undergo electivesurgery to “fail safe” a joint and/or ligaments. A football player, forexample, who is at high risk for a knee injury may choose to augment orreinforce the anterior cruciate ligament 250, posterior cruciateligament 252, tibial collateral ligament 254, fibular collateralligament 256, posterior meniscofemoral ligament 258, and/or transverseligament 260. The suture, cable, and/or graft used to reinforce theligament may be tensioned and positioned such that the natural ligamentis exclusively used during normal athletic activities. However, when thejoint (knee) is extended or dislocated beyond its normal range ofmotion, the reinforcement means (suture, cable, graft, flexible rod,etc.) engages to stop the extension or dislocation thereby preventinginjury to the joint. The engagement of the reinforcement means mayprovide a sudden stopping action when the joint or ligament is about toreach or has reached an abnormal position. Alternatively oradditionally, the engagement of the reinforcement means may provide agradual stopped action (e.g. stretching/elastic) as the joint/ligamentapproaches its maximum normal range.

The reinforcement means 182 may be implanted between bones, ligaments,and/or tendons. When the ACL is to be augmented or reinforced, thereinforcement means may extend between the femur 262, tibia 264, and/orfibula 265, may extend from the superior end of the ligament to thetibia and/or fibula, may extend from the inferior end of the ligament tothe femur, and/or may extend between the superior and inferior ends ofthe ligament itself. The reinforcement means may be positioned parallelor at an angle to the ligament. The means may be a tubular sheath 266that encapsulates the ligament, like a sheath on a wire or a braidedsheath 268 on a fuel or hydraulic line. The sheath (reinforcement means)would function as previously described, i.e. provide gradual and/orsudden stopping action to the joint/ligament.

It is contemplated that augmentation or reinforcement of ligaments andtendons of a joint for athletes or other patients be performed usingminimally invasive techniques. In the case of an athlete undergoingreinforcement or “fail safe” surgery, the surgeon must produce a minimumamount of dislocation and resection of soft tissue in order to minimizerecovery time. Furthermore, physicians could take into consideration thenatural growing rate of the athlete/patient. As the athlete grows and/orgains size and weight from physical workouts, the length, strength, andsize of joints/ligaments/tendons may change. To account for this, thereinforcement means may be modifiable using a small portal in softtissue to access the means in the joint. Once accessed, an extension 270may be added to the reinforcement means. Alternatively, thereinforcement means may include three portions. The two end portions 272may be fastened in tissue while the middle portion 274 resides betweenthe end portions. The middle portion 274 may be disconnected from theend portions 272 and replaced with a different middle portion 274 havinga different length, strength, and/or size. In this configuration, theend portions are not removed from the tissue therefore there is nohealing time required for the end portions to secure to tissue.

Example 7—Laminectomy

A laminectomy is a surgical procedure which is designed to relievepressure on the spinal cord or nerve root that is being caused by aslipped or herniated disk in the lumbar spine. A laminectomy removes aportion of bone over the nerve root or disc material from under thenerve root to give the nerve root more space and a better healingenvironment. Also, a laminectomy is effective to decrease pain andimprove function for a patient with lumbar spinal stenosis. Spinalstenosis is caused by degenerative changes that result in enlargement ofthe facet joints. The enlarged joints place pressure on the nerves.During a laminectomy, there is much muscle stripping and ligamenttearing. The back muscles or erector spinae are dissected off the laminaon both sides and at multiple levels. The facet joints, directly overthe nerve roots, are cut to give the nerve roots space. Usually, oncethe nerve roots are provided with more room, the operation is completedby closing the skin incision. The methods and devices of the presentinvention may be used to repair, reconstruct, augment, and stabilizetissue or an implant “on the way out” of the pathway created in the softtissue to access the nerve roots. Muscle may be reattached to muscle;ligaments may be repaired or reconstructed; tissue grafts may beimplanted; bones may be stabilized; and implants may be inserted.

Referring to FIG. 12, a laminectomy site is illustrated. A portion ofthe ligamentum flavum 190 is dissected and removed between two spinousprocesses 106 and 108. The distal end of the lamina 192 is removed fromthe superior spinous process 106. The laminectomy site and surroundingtissue is repaired, reconstructed, or augmented to compress andstabilize the tissue for enhanced healing. Fasteners 30 and sutures orcables 100 are placed in the adjacent vertebral bodies 82 and 84 toprovide flexible fixation of the spinal joint and limit the range ofmotion of the spine. A fastener 30 is positioned on the posterior sideof the ligamentum flavum 190 above the laminectomy site. Anotherfastener 30 is positioned on the posterior side of ligamentum flavum 190below the operation site. A suture 100 is placed between the fasteners30. The suture 100 is tensioned and secured with the fasteners 30 toprovide flexible fixation of the ligamentum flavum 190.

Another fixation device is placed between the inferior and superiorspinous processes. A fastener 30 may be positioned against one of thespinous processes 164, and a suture 100 may be wrapped between twospinous processes 164. The suture 100 may be tensioned, and the ends ofthe suture 100 may be secured with the fastener 30. This configurationprovides further flexible stabilization of the spinal column near thelaminectomy site. Finally, a ligament graft or scaffold 182 may bepositioned along the ligamentum flavum 190 over the laminectomy site.The graft 182 may reconnect and stabilize the ligamentum flavum 190. Itshould be understood that additional fasteners may be used to compressand stabilize surrounding tissue.

Example 8—Joint Stabilization

Following surgery within the body, especially surgery of a joint, thesoft tissue around and near the joint may become weakened, and the rangeof motion of the joint usually increases thereby allowing excessivetissue laxity. Also, instability of a joint may be caused by structuralchanges within the joint as a result of trauma, degeneration, aging,disease, surgery, or a combinations thereof. An unstable joint may befused to form a permanent or rigid internal fixation of all or part ofthe joint. Alternatively, joints may be stabilized with the devices andmethods of the present invention, without fusion. In an exemplaryembodiment, tissue may be repaired, reconstructed, augmented, andstabilized during and “on the way out” of a surgical procedure such asthose surgical procedures described herein. Compressing and stabilizingthe tissue around a joint enhances tissue healing. Using flexiblefixation, the tissue may be secured but still allow for some range ofmotion of the joint. Where flexible fixation is not desired, the devicesand methods of the present invention may be used for rigid fixation,such as for bones.

As a further example, fasteners and sutures could be used to stabilizethe knee joint. The sutures could be positioned between at least two ofthe femur, tibia, patella, and adjacent ligaments to stabilize the kneewithout significantly restricting the knee's normal range of motion.Moreover, the devices and methods may be used to stabilize any joint ofthe body, including the spine, shoulder, elbow, wrist, hip, knee, ankle,and joints of the hands and feet. Additionally, the present inventionmay be used with a temporal mandibular joint, SI joint, facet joint,temporomandibular joint, and sacroiliac joint.

For illustrative purposes, the present invention is described in greaterdetail with respect to the spine. FIG. 13 shows a posterior view of thehead and cervical spine with three vertebrae: C1 (Atlas), C2 (Axis), andC3. The cervical spine and head are stabilized using diagonallypositioned sutures. Fasteners 30 are positioned within or against theleft and right side of the occipital bone 200 of the head. Two otherfasteners 30 are placed within or against the left and right sides ofthe posterior arch of the C1 vertebra 202. A suture 100 extends betweenthe left fasteners 30, while another suture 100 extends between theright fasteners 30. When tensioned, the sutures 100 limit movement ofthe head relative to the cervical spine.

FIG. 13 also shows tissue graft 204, such as a ligament and/or bonegraft, positioned between a vertebra 206 and the head 208. The grafts204 may be attached using any of the devices and methods describedherein and incorporated by reference. In an exemplary embodiment,fasteners 30 are placed at the superior and inferior ends of the graft.Other fasteners (not shown) are positioned within or adjacent the bone.Sutures extend between the fasteners and are tensioned.

Further stabilization of the cervical spine may be obtained by placingsutures and fasteners lower in the cervical spine. In an exemplaryembodiment, a crisscross pattern of sutures is placed between twoadjacent vertebrae. The upper fasteners 30 may be placed within oragainst the superior vertebra 82, while the lower fasteners 30 may bepositioned within or against the inferior vertebra 84. Sutures 100extend between the fasteners, and when tensioned, the sutures 100stabilize the vertebrae 82 and 84 from movement between one another.

In another embodiment as shown in FIG. 14, a vertebra 214 has beendecompressed using fasteners and a suture. A first fastener 30 is placedwithin or adjacent an upper vertebra 212, and a second fastener 30 ispositioned within or adjacent a lower vertebra 216. A suture 100 ispositioned through the left side of the vertebrae 212, 214, and 216 in acurved, looped, or C configuration. The suture 100 is tensioned, and theends of the suture 100 secured. By tensioning the suture 100, the rightside of the middle vertebra 214 becomes decompressed.

In another exemplary embodiment, multiple vertebrae may be decompressedby positioning fasteners 30 on two vertebrae 210 and 218 which areseparated by two or more vertebrae. A tubular member or sleeve 52 ispositioned between the fasteners 30 and through the vertebrae inbetween. A suture 100 is placed within the sleeve 52, tensioned, andsecured with the fasteners 30. Moreover, the fasteners 30 may be placedon any part/portion of the vertebrae 210 and 218, as describedpreviously, so when the suture is tensioned, one or more vertebrae aredecompressed, forming a decompressed region 224.

As further seen in FIG. 14, the spine has been stabilized using thepedicles of the spine. A fastener 30 is placed within or adjacent apedicle 220. A second fastener 30 is placed within or adjacent anotherpedicle 222. A suture 100 extends between the fasteners 30 eitherthrough the pedicles or outside the pedicles. The suture 100 istensioned and the ends of the suture secured.

While FIG. 14 illustrated a suture positioned between two pedicles, itis contemplated that the suture may be affixed to any portion/part ofthe vertebrae. For example, a suture may be tensioned between any one ormore of the following: transverse process, pedicles, facets, spinousprocess, posterior arch, odontoid process, posterior tubercle, lateralarticular process, uncinate process, anterior tubercle, carotidtubercle, and vertebral body.

The suture, or similar device like a cable, band, flexible moment arm,pin, rod, or K-wire, is made of a material having sufficient strengthand fatigue characteristics. The suture may be biodegradable and/orflexible. It may include metallic material, ceramic material, polymericmaterial, composite material, or combinations thereof. In oneembodiment, the suture is formed of fiber material like carbon orpolyamide fibers. Sutures may also be formed from Mersilene®,polypropylene braided or collagen strips, allograft or xenograft strips,braided mesh, a polymer, PTFE, or GoreTex®. The suture may be made of orinclude an elastic, flexible material which stabilizes the skeletal andligamentous system but allows some movement of the joints. Also, thesuture may be barbed or could be a threaded wiring device.

The disclosed methods for spine stabilization described thus farincluded positioning fasteners against bone or an implant. However, thepresent invention also contemplates stabilizing a joint of the body byaffixing a suture between ligaments, tendons, bones, cartilage, tissuegrafts or combinations thereof. For example, a suture may be positionedbetween a vertebra and a longitudinal ligament, between a spinousprocess and the supraspinous ligament, or between a facet and a facetcapsulary ligament. Any combination of attachment points is contemplatedto stabilize the joint.

Furthermore, any of the methods described herein could utilize aplurality of sutures and more than two fasteners. The use of multiplesutures can vary the tension or resistance between the fastenerssecuring the suture, thereby providing various levels of stability. Theuse of multiple fasteners, preferably spaced apart and positionedadjacent the region of the joint to be stabilized, could provide variousangles of stabilization.

It is further contemplated that by using multiple sutures and fastenersat different locations of the spine, ligaments and bones of the spinemay be selectively tightened or stabilized to provide a customizedenvironment for spine healing. For example, the sutures may be tightenedsequentially between the fasteners, or the entire construct could betightened down together.

Related Techniques

It is contemplated that the devices and methods of the present inventionbe applied using minimally invasive incisions and techniques to preservemuscles, tendons, ligaments, bones, nerves, and blood vessels. A smallincision(s) may be made adjacent the damaged tissue area to be repaired,and a tube, delivery catheter, sheath, cannula, or expandable cannulamay be used to perform the methods of the present invention. U.S. Pat.No. 5,320,611 entitled, Expandable Cannula Having Longitudinal Wire andMethod of Use, discloses cannulas for surgical and medical useexpandable along their entire lengths. The cannulas are inserted throughtissue when in an unexpanded condition and with a small diameter. Thecannulas are then expanded radially outwardly to give a full-sizeinstrument passage. Expansion of the cannulas occurs against theviscoelastic resistance of the surrounding tissue. The expandablecannulas do not require a full depth incision, or at most require only aneedle-size entrance opening.

Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730 disclosecannulas for surgical and medical use expandable along their entirelengths. The cannula has a pointed end portion and includes wires havingcores which are enclosed by jackets. The jackets are integrally formedas one piece with a sheath of the cannula. The cannula may be expandedby inserting members or by fluid pressure. The cannula is advantageouslyutilized to expand a vessel, such as a blood vessel. An expandablechamber may be provided at the distal end of the cannula. The abovementioned patents are hereby incorporated by reference.

In addition to using a cannula with the methods of the presentinvention, an introducer may be utilized to position fasteners at aspecific location within the body. U.S. Pat. No. 5,948,002 entitled,Apparatus and Method for Use in Positioning a Suture Anchor, disclosesdevices for controlling the placement depth of a fastener. Also, U.S.patent application Ser. No. 10/102,413 discloses methods of securingbody tissue with a robotic mechanism. The above-mentioned patent andapplication are hereby incorporated by reference. Another introducer orcannula which may be used with the present invention is the VersaStep®System by Tyco® Healthcare.

The present invention may also be utilized with minimally invasivesurgery techniques disclosed in U.S. patent application Ser. No.10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078. These patentdocuments disclose, inter alia, apparatus and methods for minimallyinvasive joint replacement. The femoral, tibial, and/or patellarcomponents of a knee replacement may be fastened or locked to each otherand to adjacent tissue using fasteners disclosed herein and incorporatedby reference. Furthermore, the methods and devices of the presentinvention may be utilized for repairing, reconstructing, augmenting, andsecuring tissue or implants during and “on the way out” of a kneereplacement procedure. For example, the anterior cruciate ligament andother ligaments may be repaired or reconstructed; quadriceps mechanismsand other muscles may be repaired. The patent documents mentioned aboveare hereby incorporated by reference.

Moreover, the devices and methods of the present invention may by usedto approximate a skin incision where there may be undue tension on theskin. Fasteners may be placed on opposite sides of the incision, and asuture or cable may be placed between the fasteners. When the suture istensioned, the skin may be pulled together and held until the skintissue relaxes. Then, the fasteners may be unlocked, and the suture maybe tensioned again to further approximate the skin incision. The lockingand unlocking of the fasteners along with the tensioning of the suturemay be repeated until the incision is fully closed.

Furthermore, it is contemplated that the present invention may be usedwith bariatric surgery, colorectal surgery, plastic surgery,gastroesophageal reflex disease (GERD) surgery, or for repairinghernias. A band, mesh, or cage of synthetic material or body tissue maybe placed around an intestine or other tubular body member. The band mayseal the intestine. This method may be performed over a balloon orbladder so that anastomosis is maintained. The inner diameter of thetubular body part is maintained by the balloon. The outer diameter ofthe body part is then closed or wrapped with a band, mesh, or patch. Theinner diameter of the tubular body member may be narrowed or restrictedby the band. The band may be secured to the tubular body part orsurrounding tissue with the devices and methods described herein andincorporated by reference.

In addition, intramedullary fracture fixation and comminuted fracturefixation may be achieved with the devices and methods of the presentinvention. For example, a plate or rod may be positioned within oragainst the fractured bone. A fastener may be driven across the bone andlocked onto the plate, rod, or another fastener.

It is further contemplated that the present invention may be used inconjunction with the devices and methods disclosed in U.S. Pat. No.5,329,846 entitled, Tissue Press and System, and U.S. Pat. No. 5,269,785entitled, Apparatus and Method for Tissue Removal. For example, animplant secured within the body using the present invention may includetissue harvested, configured, and implanted as described in the patents.The above-mentioned patents are hereby incorporated by reference.

Additionally, it is contemplated that the devices and methods of thepresent invention may be used with heat bondable materials as disclosedin U.S. Pat. No. 5,593,425 entitled, Surgical Devices Assembled UsingHeat Bondable Materials. For example, the fasteners of the presentinvention may include heat bondable material. The material may bedeformed to secure tissue or hold a suture or cable. The fasteners madeof heat bondable material may be mechanically crimped, plasticallycrimped, or may be welded to a suture or cable with RF (Bovie devices),laser, ultrasound, electromagnet, ultraviolet, infrared,electro-shockwave, or other known energy. The welding may be performedin an aqueous, dry, or moist environment. The welding device may bedisposable, sterilizable, single-use, and/or battery-operated. Theabove-mentioned patent is hereby incorporated by reference.

Furthermore, it is contemplated that the methods of the presentinvention may be performed under indirect visualization, such asendoscopic guidance, computer assisted navigation, magnetic resonanceimaging, CT scan, ultrasound, fluoroscopy, X-ray, or other suitablevisualization technique. The implants, fasteners, fastener assemblies,and sutures of the present invention may include a radiopaque materialfor enhancing indirect visualization. The use of these visualizationmeans along with minimally invasive surgery techniques permitsphysicians to accurately and rapidly repair, reconstruct, augment, andsecure tissue or an implant within the body. U.S. Pat. Nos. 5,329,924;5,349,956; and 5,542,423 disclose apparatus and methods for use inmedical imaging. Also, the present invention may be performed usingrobotics, such as haptic arms or similar apparatus. The above-mentionedpatents are hereby incorporated by reference.

Moreover, the fasteners and methods of the present invention may be usedfor the repair and reconstruction of a tubular pathway like a bloodvessel, intestine, urinary tract, esophagus, or other similar bodyparts. For example, a blood vessel may be intentionally severed during asurgical operation, or the blood vessel may be damaged or torn as aresult of an injury. Flexible fixation of the vessel would permit thevessel to function properly and also compress and stabilize the vesselfor enhanced healing. To facilitate the repair or reconstruction of abody lumen, a balloon may be inserted into the lumen and expanded so thedamaged, severed, or torn portion of the vessel is positioned againstthe outer surface of the inflated balloon. In this configuration, thefasteners and methods described and incorporated herein may be used toapproximate the damaged portion of the vessel.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed herein above. In addition, unless mention was made above tothe contrary, it should be noted that all of the accompanying drawingsare not to scale. A variety of modifications and variations are possiblein light of the above teachings without departing from the scope andspirit of the invention.

I claim:
 1. A surgical method for ligament augmentation comprising:securing a first end of a reinforcement member with a first fastener toa first bone of a joint adjacent an attachment of a first end of aligament to the first bone, wherein the first end of the ligament isattached to the first bone of the joint independent of the reinforcementmember and the first fastener; and securing a second end of thereinforcement member with a second fastener to a second bone of thejoint adjacent an attachment of a second end of the ligament to thesecond bone, wherein the second end of the ligament is attached to thesecond bone of the joint independent of the reinforcement member and thesecond fastener, wherein the reinforcement member extends between thefirst and second fasteners, and wherein the reinforcement member is freefrom attachment to the ligament between the first and second fasteners.2. The surgical method for ligament augmentation set forth in claim 1,further comprising tensioning the reinforcement member between the firstand second fasteners.
 3. The surgical method for ligament augmentationset forth in claim 1, wherein the ligament is a medial collateralligament.
 4. The surgical method for ligament augmentation set forth inclaim 1, wherein the reinforcement member is a multifilament structurecomprised of at least one of polyethylene, polyester, and collagen. 5.The surgical method for ligament augmentation set forth in claim 4,wherein the reinforcement member is at least one of a band and a flattape.
 6. The surgical method for ligament augmentation set forth inclaim 1, wherein at least one of the first fastener and the secondfastener is threaded.
 7. The surgical method for ligament augmentationset forth in claim 1, wherein at least one of the first fastener and thesecond fastener is comprised of two components, wherein one of the twocomponents is hollow and threaded.
 8. The surgical method for ligamentaugmentation set forth in claim 1, wherein the ligament is a ligament ina hand.
 9. The surgical method for ligament augmentation set forth inclaim 1, wherein ligament is a ligament in the ankle.
 10. The surgicalmethod for ligament augmentation set forth in claim 1, wherein theligament is a ligament in a foot.
 11. The surgical method for ligamentaugmentation set forth in claim 1, wherein the ligament is a ligament ina knee.
 12. The surgical method for ligament augmentation set forth inclaim 1, wherein the reinforcement member is secured to augment theligament when the ligament is at least one of repaired andreconstructed.
 13. The surgical method for ligament augmentation setforth in claim 1, wherein the ligament is a ligament in a wrist.
 14. Thesurgical method for ligament augmentation set forth in claim 1, whereinthe reinforcement member is a plurality of reinforcement members.
 15. Asurgical method for ligament augmentation comprising: securing a firstend of a reinforcement member with a first fastener to a first bone of ajoint adjacent a first end of a ligament of the joint; and securing asecond end of the reinforcement member with a second fastener to asecond bone of the joint adjacent a second end of the ligament of thejoint, wherein the first end of the ligament is attached to the firstbone of the joint independent of the first fastener securing the firstend of the reinforcement member to the first bone, and the second end ofthe ligament is attached to the second bone of the joint independent ofthe second fastener securing the second end of the reinforcement memberto the second bone, and wherein the reinforcement member is free fromattachment to the ligament between the first and second fasteners. 16.The surgical method for ligament augmentation set forth in claim 15,further comprising tensioning the reinforcement member between the firstand second fasteners.
 17. The surgical method for ligament augmentationset forth in claim 15, wherein at least one of the first fastener andthe second fastener is threaded.
 18. The surgical method for ligamentaugmentation set forth in claim 15, wherein the reinforcement member isa multifilament structure comprised of at least one of polyethylene,polyester, and collagen.
 19. The surgical method for ligamentaugmentation set forth in claim 18, wherein the reinforcement member isat least one of a band and a flat tape.
 20. The surgical method forligament augmentation set forth in claim 15, wherein the ligament is aligament in a hand.
 21. The surgical method for ligament augmentationset forth in claim 15, wherein ligament is a ligament in the ankle. 22.The surgical method for ligament augmentation set forth in claim 15,wherein the ligament is a ligament in a foot.
 23. The surgical methodfor ligament augmentation set forth in claim 15, wherein the ligament isa ligament in a knee.
 24. The surgical method for ligament augmentationset forth in claim 15, wherein the ligament is a medial collateralligament.
 25. The surgical method for ligament augmentation set forth inclaim 15, wherein the ligament is a ligament in a wrist.
 26. Thesurgical method for ligament augmentation set forth in claim 15, whereinat least one of the first fastener and the second fastener is comprisedof two components, wherein one of the two components is hollow andthreaded.
 27. The surgical method for ligament augmentation set forth inclaim 15, wherein the reinforcement member is a plurality ofreinforcement members.